It was reported that during an angioplasty procedure in the upper arm, the pta balloon allegedly ruptured at 20 atm, on the second inflation attempt.It was further reported that during removal of the device, balloon material detached and migrated to the heart.The patient was transported to the hospital for retrieval of the detached material.The patient is reportedly stable.
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H10: manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required, as this is the first complaint for the reported lot number.Investigation summary: the device was returned for evaluation.A visual inspection was performed.The sample appeared to be clean.The balloon and the distal tip of the catheter were noted to be detached but were not included in the returned package.The marker bands were still present on the catheter.The guidewire lumen was noted to be exposed.The glue bullet was noted to be pulled from its original position.Remains of balloon material were noted at the proximal balloon joint.The returned segment measured approximately 81.4cm from the strain relief to the break.No further functional testing or evaluations were performed due to the state of the device.Therefore, the investigation is confirmed for the reported balloon detachment, as the balloon noted to be detached from the catheter was not returned for evaluation.The investigation is inconclusive for the reported balloon rupture, as the balloon was not returned for evaluation.The reported balloon rupture may have contributed to the detachment issue.However, the definitive root cause for the reported balloon rupture, and detachment could not be determined based upon available information.It is unknown whether patient or procedural issues contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
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It was reported that during an angioplasty procedure in the upper arm, the pta balloon allegedly ruptured at 20 atm, on the second inflation attempt.It was further reported that during removal of the device, balloon material detached and migrated to the heart.The patient was transported to the hospital for retrieval of the detached material.The patient is reportedly stable.
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